title: Clinical experience with insulin detemir in patients with type 2 diabetes from the near East countries.
abstract: BACKGROUND
  This study aimed at determining the clinical safety and efficacy of insulin detemir (IDet) in combination with oral anti-diabetic drugs (OADs) in type 2 diabetes (T2D) patients from four Near East Countries (Israel, Jordan, Pakistan and Lebanon).
  
  
  METHODS
  This prospective observational study included T2D patients previously on OADs and newly diagnosed patients initiating IDet with or without OADs, at the discretion of physicians. Safety objectives included evaluation of hypoglycemia and adverse drug reactions (ADRs) from baseline to Week 24. Efficacy outcomes included baseline to Week 24 changes in glucose control parameters (glycated hemoglobin [HbA1c], fasting plasma glucose [FPG] and post-breakfast post-prandial plasma glucose [PPPG]). Change in body weight during this period was also assessed.
  
  
  RESULTS
  A total of 2,155 patients (mean ± SD: age 57.1 ± 11.0 years, BMI 29.4 ± 5.1 kg/m(2), average diabetes duration 9.2 ± 5.4 years) were included. IDet dose at baseline was 0.20 ± 0.09 U/kg titrated up to 0.34 ± 0.14 U/kg by Week 24. From baseline to Week 24, the total number of hypoglycemic episodes increased from 1.30 to 1.37 events/patient-year, while major hypoglycemic episodes decreased from 0.15 to 0.02 events/patient-year. A total of 9 ADRs were reported, of which one event was a serious ADR. Statistically significant improvements in glucose control were reported from baseline to Week 24 (HbA1c: 9.6 ± 1.6% vs. 7.6 ± 1.1%; FPG: 201.5 ± 59.5 mg/dL vs. 124.9 ± 31.6 mg/dL; PPPG: 264.2 ± 65.7 mg/dL vs. 167.2 ± 36.8 mg/dL; all p < 0.0001). Body weight did not change significantly after 24 weeks of IDet therapy.
  
  
  CONCLUSIONS
  IDet therapy in combination with OADs improved glycemic control without increasing the risk of hypoglycemia or weight gain.
authors.affiliation: Rafic Hariri University Hospital, Beer Hassan, Beirut, Lebanon, akramechtay@hotmail.com.
authors.forename: Akram
authors.initials: A
authors.lastname: Echtay
authors.forename: Anat
authors.initials: A
authors.lastname: Tsur
authors.forename: Mohammad I
authors.initials: MI
authors.lastname: Hasan
authors.forename: M Omar
authors.initials: MO
authors.lastname: Abu-Hijleh
authors.forename: Nidal
authors.initials: N
authors.lastname: Al Khatib
authors.forename: Emile
authors.initials: E
authors.lastname: Andari
authors.forename: Paola
authors.initials: P
authors.lastname: Atallah
authors.forename: Saleem
authors.initials: S
authors.lastname: Qureshi
authors.forename: Jamal
authors.initials: J
authors.lastname: Zafar
authors.forename: Levent
authors.initials: L
authors.lastname: Sandalci
authors.forename: Asude
authors.initials: A
authors.lastname: Ademogulları
authors.forename: Jihad
authors.initials: J
authors.lastname: Haddad
authors.forename: Bracha
authors.initials: B
authors.lastname: Dagan